JaundiceNCT02224586
Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.
An observational study of Jaundice, run by Hangzhou Normal University at 1 site in China.
Trial summary
It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Jaundice
- What is being tested?
- light treatment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: municipal hospitals
Who may be able to join
- hyperbilirubinemia
Who cannot join
- asphyxia
- cerebral dysgenesis
Trial locations and contacts
1 site in 1 country.
Xiao-Bao Xue contact
China1 site, 1 recruiting
- Recruiting
Center for Cognition and Brain Disorders
Hangzhou, Zhejiang, 311121
Xiao-Bao Xue, baobao871015@163.com
Ya-Fei Zhu
About this study
It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of ASL is cerebral blood flow (CBF).
The investigates assume that the children with jaundice after light therapy, ALFF and CBF will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were proved to be abnormal in MRI T1, T2 structure signal in kernicterus.
Doctors observe the status of infants aside.Using monitoring probe can see clearly.
Read the detailed description
resting state fMRI scan light therapy the second time resting state fMRI scan
- Conditions
- Jaundice
- Being tested
- light treatment
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light treatmentDevice
clinical routine treatment according to the doctor's advice
| Study group | Role | What they receive |
|---|---|---|
| light treatment | clinical routine treatment according to the doctor's advice Receives: Device: light treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude of low-frequency fluctuation change before and after light treatment
It is indicator of blood oxygenation level dependent.
Measured: before and after light treatment
Secondary outcomes (1)
cerebral blood flow change before after light treatment
It is indicator of arterial spin labeling.
Measured: before and after light treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Fei Zhu, Hangzhou Normal University
- Investigators
- Ya-Fei Zhu, Principal investigator, Center for Cognition and Brain Disorders,Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224586
- Sponsor's protocol ID
- HNU_AH_jaundice fMRI
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.
- ClinicalTrials.gov ID
- NCT02224586
- Acronym / sponsor ID
- HNU_AH_jaundice fMRI
- Conditions
- Jaundice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of ASL is cerebral blood flow (CBF).
The investigates assume that the children with jaundice after light therapy, ALFF and CBF will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were proved to be abnormal in MRI T1, T2 structure signal in kernicterus.
Doctors observe the status of infants aside.Using monitoring probe can see clearly.
Detailed description
resting state fMRI scan light therapy the second time resting state fMRI scan
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| light treatment | – | Device: light treatmentclinical routine treatment according to the doctor's advice |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- municipal hospitals
Key inclusion criteria (1 listed)
- hyperbilirubinemia
Key exclusion criteria (2 listed)
- asphyxia
- cerebral dysgenesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light treatmentclinical routine treatment according to the doctor's advice | Device | light treatment |
Primary outcome
amplitude of low-frequency fluctuation change before and after light treatment
Time frame: before and after light treatment
It is indicator of blood oxygenation level dependent.
1 secondary outcome
cerebral blood flow change before after light treatment
Time frame: before and after light treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-Bao Xue contact
Ya-Fei Zhu principal investigator
Center for Cognition and Brain Disorders,Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Bao Xue (baobao871015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude of low-frequency fluctuation change before and after light treatment (time frame: before and after light treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.